P
US7927618B2ExpiredUtilityPatentIndex 82

Implants, particles

Assignee: ROVI LAB FARMACEUT SAPriority: Jan 11, 2000Filed: Jul 10, 2002Granted: Apr 19, 2011
Est. expiryJan 11, 2020(expired)· nominal 20-yr term from priority
Inventors:BODMEIER ROLAND
A61L 2300/602A61L 27/54A61K 9/0019A61K 9/204A61L 2300/802A61K 47/34A61L 27/18A61K 47/36A61K 47/14A61L 27/26A61K 47/44A61K 9/1274A61K 9/0024
82
PatentIndex Score
16
Cited by
53
References
41
Claims

Abstract

This invention relates to kits for the preparation of a composition, which comprises a carrier phase that forms an implant or particles in the body, on the body or under physiological conditions. The carrier phase comprises at least one solid carrier material and a solvent, wherein the carrier material and the solvent are stored separately in the kit. The kit can also include an additional liquid phase to aid in forming the particles. An active compound included in the carrier phase is generally released in an extended manner. This invention also relates to compositions prepared from this kit and to methods for the preparation of the kits and the composition.

Claims

exact text as granted — not AI-modified
1. A kit for the preparation of a composition comprising a carrier phase, which forms an implant or particles in a body, on a body or under physiological conditions, the kit comprising: a first container containing at least one solid or semisolid carrier material; and a second container containing an amount of solvent sufficient to dissolve the carrier material, wherein the carrier material is separate from the solvent; wherein the carrier material is sufficiently soluble in the solvent so that it dissolves in the solvent within less than 60 minutes, if placed in contact and mixed therewith, thereby rapidly forming an administrable carrier phase comprising a polymer solution; the carrier material is a powder or lyophile; the solvent comprises water and/or one or more water-miscible organic solvents when the carrier material is water soluble; the solvent comprises one or more organic solvents when the carrier material is water insoluble; and wherein the administrable carrier phase forms an implant or particles in situ after being placed in a body, on a body or under physiological conditions. 
     
     
       2. A kit according to  claim 1 , wherein the carrier material and the solvent are stored in separate syringes or in separate chambers of a multi-chamber syringe such that when the carrier material is mixed with the solvent, prior to administration, through a connector or within a multi-chamber syringe, the carrier material is at least partially dissolved in the solvent. 
     
     
       3. A kit according to  claim 1  or  2 , wherein the carrier material comprises a water-soluble polymer, a water-insoluble polymer, a polymer that is soluble in aqueous fluids, a biocompatible and/or biodegradable polymer, a protein, a lipid, a non-polymeric material or a combination thereof. 
     
     
       4. A kit according to  claim 3 , wherein the carrier material comprises a poly(lactide) or poly(lactide)-derivative or copolymer, a monoglyceride, sucroseacetateisobutyrate or a combination thereof. 
     
     
       5. A kit according to  claim 3 , wherein the composition forms cubic or liquid crystalline phases in the body, on the body or under physiological conditions. 
     
     
       6. A kit according to  claim 3 , wherein the solvent is water or an organic solvent selected from the group consisting of ethanol, acetone, butanol, ethylformate, acetic acid, pentanol, n- or iso-propanol, tetrahydrofuran, triethylcitrate, triacetin, propylene glycol, glycerol, polyethylene glycol, ethylacetate, methylacetate, ethyllactate, benzylalcohol, dimethylformamide, dimethylsulfoxide, dimethylacetamide, propylenecarbonate, glycofurol, oleic acid, 2-pyrrolidone, N-methyl-2-pyrrolidone, an oil, a plasticizer and a mixture of two or more of these solvents. 
     
     
       7. A kit according to  claim 3 , wherein a portion of the carrier material is present in the solvent prior to mixing of the solvent with the solid carrier material. 
     
     
       8. A kit according to  claim 3 , wherein the composition further comprises at least one active compound. 
     
     
       9. A kit according to  claim 8 , wherein the active compound is encapsulated. 
     
     
       10. A kit according to  claim 8 , wherein the active compound in the kit is mixed with the carrier material, is present in the solvent or both. 
     
     
       11. A kit according to  claim 8 , wherein the composition further comprises a viscosity-modifying substance, stabilizer, release modifying agent, pore-former, substance that changes the residence time of the active compound or composition at a site of administration, bioadhesive material, penetration enhancer, substance for the retardation of the release of active compound, substance for the avoidance of a rapid initial release of active compound at a site of administration or a combination thereof. 
     
     
       12. A kit according to  claim 8 , wherein the composition is adapted for parenteral, peroral, subcutaneous, rectal, buccal, ophthalmic, pulmonary, vaginal, nasal, local, sublingual, periodontal, or transdermal administration, for application into a body cavity or for application onto a body surface. 
     
     
       13. A kit according to  claim 8 , wherein the composition is adapted for the treatment of soft- and hard tissue defects, treatment of tissue regeneration, use as glue, filling of a body cavity, or the treatment of a wound. 
     
     
       14. A kit according to  claim 8 , wherein the composition further comprises an additional liquid phase in which the administrable carrier phase can be dispersed to form a dispersion. 
     
     
       15. A kit according to  claim 14 , wherein the additional liquid phase is stored in the kit separate from the carrier material and the solvent, is in contact with the carrier material and separate from the solvent, or is in contact with the solvent and separate from the carrier material. 
     
     
       16. A kit according to  claim 14 , wherein the additional liquid phase comprises natural, semisynthetic or synthetic lipids, oils or waxes; triglyceride mixture; monoglyceride; silicone oil; isopropylmyristate; ethyloleate; paraffin; water; glycerol; propylene glycol; polyethylene glycol; or a mixture thereof. 
     
     
       17. A kit according to  claim 14 , wherein the at least one active compound is present together with one or more of the carrier material, solvent or additional liquid phase. 
     
     
       18. A method for the preparation of a kit, the method comprising the steps of:
 including a carrier material in solid or semisolid form in a syringe or in a chamber of a multi-chamber syringe, wherein the carrier material is a powder or lyophile; and 
 including a solvent for the carrier material in a separate syringe or separate chamber of the multi-chamber syringe, wherein the solvent comprises one or more water and/or one or more water-miscible organic solvents when the carrier material is water soluble; the solvent comprises one or more organic solvents when the carrier material is water insoluble; 
 wherein the solvent is present in an amount sufficient to dissolve the carrier material, the carrier material is sufficiently soluble in the solvent so that it dissolves in the solvent within less than 60 minutes when placed in contact therewith and mixed to rapidly form an administrable carrier phase, and the administrable carrier phase forms an implant or particles in situ after being placed in a body, on a body or under physiological conditions. 
 
     
     
       19. A method according to  claim 18 , the step of including the carrier material comprises the step of:
 placing the carrier material in solution or dispersion form in the syringe or the chamber of the multi-chamber syringe; and 
 drying or lyophilizing the carrier material to form a solid or semisolid. 
 
     
     
       20. A method according to  claim 18  or  19 , wherein the carrier material is a water-soluble polymer, a water-insoluble polymer, a polymer that is soluble in aqueous fluids, a biocompatible and/or biodegradable polymer, a protein, a lipid, a non-polymeric material or a combination thereof. 
     
     
       21. A method according to  claim 18  or  19  further comprising the step of:
 including at least one active compound present separately, mixed with the carrier material, mixed with the solvent or mixed with both the carrier material and the solvent such that the at least one active compound is included within the carrier phase. 
 
     
     
       22. A method according to  claim 18  or  19  further comprising the step of:
 including an additional liquid phase for dispersion of the carrier phase when mixed therewith, wherein the additional liquid phase is stored in the kit separate from the carrier material and the solvent, is in contact with the carrier material and separate from the solvent, or is in contact with the solvent and separate from the carrier material. 
 
     
     
       23. A method according to  claim 22  further comprising the step of:
 including at least one active compound present separately, or present as a mixture with the carrier material, solvent, additional liquid phase or a combination thereof such that the at least one active compound is included within the carrier phase and/or additional liquid phase. 
 
     
     
       24. A method for the preparation of an implant or particulate composition in situ after being placed in a body, on a body or under physiological conditions, the method comprising the steps of:
 providing at least one solid or semisolid carrier material and solvent in separate syringes or separate compartments of a multi-compartment syringe, wherein carrier material is a powder or lyophile, the solvent is present in an amount sufficient to dissolve the carrier material if placed in contact and mixed therewith, the solvent comprises water and/or one or more water-miscible organic solvents when the carrier material is water soluble, the solvent comprises one or more organic solvents when the carrier material is water insoluble; 
 mixing the carrier material and solvent such that the carrier material dissolves in the solvent within less than 60 minutes thereby forming an administrable carrier phase; and 
 administering the carrier phase by placing it within or on a subject or by exposing it to a physiological condition thereby forming the implant or particulate composition in situ. 
 
     
     
       25. A method according to  claim 24 , wherein the carrier material is a water-soluble polymer, a water-insoluble polymer, a polymer that is soluble in aqueous fluids, a biocompatible and/or biodegradable polymer, a protein, a lipid, a non-polymeric material or a combination thereof. 
     
     
       26. A method according to  claim 24  or  25  further comprising the step of:
 including at least one active compound present separately, mixed with the carrier material, mixed with the solvent or mixed with both the carrier material and the solvent. 
 
     
     
       27. A method according to  claim 24  or  25  further comprising the step of:
 including an additional liquid phase, wherein the additional liquid phase is stored in the kit separate from the carrier material and the solvent, is in contact with the carrier material and separate from the solvent, or is in contact with the solvent and separate from the carrier material; and the additional liquid phase forms a particulate dispersion with the carrier phase when mixed therewith. 
 
     
     
       28. A method according to  claim 27  further comprising the step of:
 including at least one active compound present separately, or present as a mixture with the carrier material, solvent, additional liquid phase or a combination thereof. 
 
     
     
       29. A kit according to  claim 8 , wherein the implant or particles provide an extended release of active compound when placed in the body, on the body or under physiological conditions. 
     
     
       30. A kit according to  claim 14 , wherein the implant or particles provide an extended release of active compound when placed in the body, on the body or under physiological conditions. 
     
     
       31. A method according to  claim 21 , wherein the carrier phase provides an extended release of active compound when placed in a body, on a body or under physiological conditions. 
     
     
       32. A method according to  claim 23 , wherein the carrier phase provides an extended release of active compound when placed in a body, on a body or under physiological conditions. 
     
     
       33. A method according to  claim 26 , wherein the implant or particles provide an extended release of active compound. 
     
     
       34. A method according to  claim 28 , wherein the implant or particles provide an extended release of active compound. 
     
     
       35. A kit according to  claim 2 , wherein at least 75% wt. of the carrier material dissolves in the solvent to form the polymer solution. 
     
     
       36. A kit according to  claim 35 , wherein the carrier material dissolves in the solvent in less than 5 minutes. 
     
     
       37. A kit according to  claim 35 , wherein the carrier material dissolves in the solvent in less than 30 minutes. 
     
     
       38. A kit according to  claim 35 , wherein the carrier material dissolves in the solvent in less than 20 minutes. 
     
     
       39. A kit according to  claim 35 , wherein the carrier material dissolves in the solvent in less than 10 minutes. 
     
     
       40. A kit according to  claim 35 , wherein the carrier material dissolves in the solvent in less than 1 minute. 
     
     
       41. A kit according to  claim 1 , wherein the carrier material is porous.

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